BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER

    MDR report key: 2862297 · Received November 29, 2012

    Report

    Report Number
    9681684-2012-00095
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 4, 2012
    Report Date
    November 5, 2012
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH ON BEHALF OF THE MFR ARJOHUNTLEIGH (B)(4). ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    WHILE THE RESIDENT WAS BEING LIFTED WITH A PORTABLE CEILING LIFT, THE STITCHES OF THE LIFTING STRAP CAME OFF AND THE RESIDENT FELL OFF. NO INJURIES WERE REPORTED TO EITHER THE CAREGIVER OR RESIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER MANUFACTURED PORTABLE CASSETTES FNG ARJOHUNTLEIGH MAGOG INC. VOYAGER

    Patients

    Seq Age Sex Outcome Treatment
    1